The FDA, Congress, the Supreme Court, Democrats, Republicans and Pharmaceutical Companies entaggled in an epic struggle about the safety or preemption from product liability for Drugs and Medical Devices. A struggle that will directly impact the health of Americans and the profits of drug and device companies.

Friday, August 29, 2008

Here is an interview with Dr. David Graham (senior drug safety researcher at the FDA) that was held exactly 3 years ago. Seems things haven't changed much from then. Lets hope that as the dead lines for preemption approach some real change will begin to get traction.As you read this interview you will be impress with Dr. Graham's wisdom, honesty and bravery in the face of the FDA bureaucracy.

1 comment:

Anonymous
said...

The Conversion of Our Protector

The Food and Drug Administration (FDA) originated in its original form several decades ago, with their objective being to ensure the health and safety of the citizens of the United States regarding products that they consume, and the catalyst for its development was due to the concepts originated by a man named Upton Sinclair. However, the objective of the FDA seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry possibly through the money that this industry gives the FDA for various reasons, so it seems. This is such a large amount of funds issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income for various reasons. Results of this relationship, one could posit, have been the approval of unsafe drugs on occasion and lack of sufficient regulation and monitoring of the pharmaceutical industry and their products that the FDA is obligated to perform- due largely to the FDA being perhaps intentionally understaffed. As a result, the FDA lacks sufficient resources, perhaps by design, to complete their duties completely, they have said. Annually, the FDA receives nearly fifty thousand illegal promotional pharmaceutical material items, and all they do is lightly warn the manufacturers of these items to discontinue their use- absent of any penalty or restriction of the violating pharmaceutical company. Yet the anger and sadness of many others about this protector of the public is due to the FDA's own mission statement, which claims that they will always protect, advance, and improve public health. An example of this support from the pharmaceutical industry is the Prescription Drug User Fee Act, which requires drug companies to pay around a million dollars for a priority review of a potentially approvable drug of theirs. Implemented by the FDA in 1992, it has required increases in the amounts paid by drug companies since then. In fact, of the FDA's estimated 2 billion dollar budget, about 20 percent of this money is from this act. Since 1992 and the implementation of this act, there have been no less than 12 drug recalls, which statistically is significant. To improve public health, it may be best that the FDA receive all funding from the U.S. Treasury, and not the ones who they are required to assess and regulate. DTCA campaigns continue for long periods of time for similar reasons of insufficient manpower at the FDA.So this intimacy between the FDA and pharmaceutical industry seems to continue to progress, as illustrated with the recent proposal by the FDA to allow the pharmaceutical industry's reps to discuss their products with prescribers off-label. This indicates that the FDA tacitly approves inappropriate activity by the pharmaceutical industry which may harm the health of others.A prescriber, upon their own discretion, can in fact prescribe a drug off-label. Historically, however, and for good reasons, representatives from the pharmaceutical industry have been prohibited from suggesting or discussing off-label potential uses of their promoted products with prescribers due to the speculative nature of the concept. In fact, it is a federal offense for pharmaceutical companies to speak off-label about the drugs they promote, and some have been penalized for this behavior in the past in the form of monetary settlements by the Department of Justice, yet appears such penalties are not much of a deterrent for this behavior that may now be authorized and has continued to occur, and now with the FDA agreeing with this activity, apparently. This suggested FDA protocol that is being considered regarding this inappropriate promotion of drugs is called, “Good Reprint Practices”, and the proposal would require reps to use what in fact may not truly exist, which is completely truthful and authentic clinical trials related to off-label possibilities of their promoted products during any dialogues they may have with prescribers. This in itself may lack a necessary degree of validity for such discussions by reps, as it has been suspected that some clinical trials are flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials through possibly third parties, such as trial deception involving ghostwriting and invalid authors of such trials, as with the case in seeding trials, which disintegrates the quality of such a study. These facts can be validated and have been discovered by others, so caution instead of autonomy should be utilized regarding clinical trial discussions with health care providers, some may say.Furthermore, this proposal is additionally flawed due to the fact that most pharmaceutical reps have little of any clinical research training to analyze such clinical trials. So the ability for pharmaceutical representatives to analyze data from trials justifying an off-label concept is unlikely beneficial for the medical community. This complicates the idea of this off-label concept- this ignorance of most drug representatives in regards to the complexities of these once reliable and dependable methods of proof, and that is the clinical trials. In addition, the proposed relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted medications, as they disregard the health of the consumers of these medications, potentially. So, our previous public health safety administration, the FDA, appears to be evolving into taking somewhat of an apathetic stance regarding the safety of the public health by suggesting such practices with what appears to be deliberate intent and reckless disregard for our citizens. Even though they lack resources, the FDA now appears to view the pharmaceutical industry as their sponsor or client. It is amazingly unbelievable this proposal ever came into existence- with the delusional fallacy the FDA stated to others that it would be an actual benefit to public health. Furthermore, this FDA proposal may complicate existing patient medication errors, such as in the elderly or dosing for children, and is also complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing medications correctly. However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with medications upon dialogue with prescribers, instead of the pharmaceutical sales representatives, who, unlike those who may be more academically enriched, have the sole objective of increasing the market share of their promoted drugs. Such people, ideally, would not have any association with the makers of such drugs spoken about to prescribers, yet this may be unlikely to occur. Regardless, awareness needs to be achieved by the public about the possible dangers of this FDA proposal, as well as the FDA itself. As citizens, we have the right to insist that the FDA demand and direct the pharmaceutical company to prevent potential harm that may come to patients in need instead of their apparent desire to please their employer.. More congressional oversight is needed of this Association, and more need to be aware of how the FDA has regressed since its birth.

"It is difficult to get a man to understand something when his salary depends upon his not understanding it." --- Upton Sinclair